2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC2009
Submitter : Ms. Bridget Gibbons Date & Time: 10/31/2005 05:10:54
Organization : Ms. Bridget Gibbons
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
Yes. The FDA already does this for nicotine replacement drugs, and in the interest of legislative clarity, a clear rule should be established for drugs available in both prescription and OTC. This will finally allow the FDA to make a decision regarding Plan B, a decision consumers have waited on for years.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
Yes. Such a rule will clarify this rule for future drugs so that consumers will have easier access to drugs. As the pharmaceutical industry becomes more and more involved in the everyday lives of Americans, increasing ease and access will aid both industry and consumers in making the right drug choices free from the need for prescriptions for drugs determined to be safe for OTC by the FDA.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I disagree that there is confusion over this issue. I believe that the confusion surrounding Plan B stems from religious and political disagreement with the drug itself. However, if a clarification of the rule will allow the FDA to finally make a decision regarding Plan B, I would approve of a rulemaking in order to facilitate decisionmaking.
C. If so, would a rulemaking on this issue help dispet that confusion?
As stated above, I think the "confusion" is merely a political smokescreen. However, future drugs may cause legitimate confusion, so perhaps it is in the best interest of the consumer population to have a bright-line rule regarding these drugs.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
Absolutely. Although I personally disagree that there should be an age limit on access to Plan B, there are already age limitations on other drugs like Nicoderm and Nicorette. As a matter of public policy, it is up to the legislature to determine age limits, as the FDA commission has tried to
do, despite interference from outside sources.
B. If it could, would it be able to do so as practical matter and, if so, how?
The FDA already only allows nictoine drugs to be dispensed to those over 18. Adults present an ID to get their product. Any other drug could be enforced in the same manner.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Yes. There is no reason to make arbitrary distinctions in packaging as long as the content of the drug is the same. As long as the products are substantially the same product, with no difference in content or dosage, there is no reason to require different packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If the products differed in dosage or content, it would be inappropriate to sell them in a single package.
GENERAL
GENERAL
The delay in approving Plan B is a political smokescreen. The deception on the part of certain staff members at the FDA goes against the agreement reached with Senators Clinton and Murray this past summer. Either approve or deny this product. Follow your own policy. Remain independent and act in the best interest of the population. Please.